Dry Eye SyndromeNCT00544713

Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery

A study testing Carboxymethylcellulose and Glycerin based artificial tear and Carboxymethylcellulose in people with Dry Eye Syndrome, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dry Eye Syndrome
What is being tested?: Carboxymethylcellulose and Glycerin based artificial tear and Carboxymethylcellulose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 228 participants
Where: 1 siteUnited States
Study dates: Sep 2007to Jun 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters

Who cannot join

Dry eye signs and symptoms
Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively
Pregnancy or planning pregnancy
Uncontrolled systemic disease
Use of systemic medications affecting dry eye

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
San Diego, California

Other trials in United States

About this study

This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery

Conditions: Dry Eye Syndrome
Being tested: Carboxymethylcellulose and Glycerin based artificial tear, Carboxymethylcellulose
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carboxymethylcellulose and Glycerin based artificial tearDrug
As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake
CarboxymethylcelluloseDrug
Also called Refresh Plus®
As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake

Study groups in NCT00544713
Study group	Role	What they receive
Carboxymethylcellulose and Glycerin based artificial tear	Experimental	Carboxymethylcellulose and Glycerin based artificial tear Receives: Drug: Carboxymethylcellulose and Glycerin based artificial tear
Carboxymethylcellulose based artificial tear	Active comparator	Carboxymethylcellulose based artificial tear Receives: Drug: Carboxymethylcellulose

What is being measured

The primary outcome is the main question the study is designed to answer.

Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90
Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).
Measured: Day 90

Secondary outcomes (11)

Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
A questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (referred to as AT). Percentage of patients responding either "Agree" or "Strongly Agree" at day 90 was tabulated. The potential response categories included "Strongly Agree", "Agree", "Neither Agree Nor Disagree", "Disagree" and "Strongly Disagree".
Measured: Day 90
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
A patient acceptability - sensory questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (AT). Percentage of patients responding either "Agree" or "Strongly Agree" at day 90 was tabulated. The potential response categories included "Strongly Agree", "Agree", "Neither Agree Nor Disagree", "Disagree" and "Strongly Disagree".
Measured: Day 90
Best Corrected Visual Acuity (BCVA) Status at Day 90
BCVA status at Day 90 reported as the number of patients whose scores were either "Better", "No Change", or "Worse" than their scores at baseline. The status was tabulated as number of lines read correctly at Day 90 minus the number of lines read correctly at baseline. "Better" equals increase of 2 lines or more; "No Change" equals change between -2 to +2 lines; "Worse" equals decrease of 2 lines or more. BCVA is measured using a special eye chart a nd is reported as the number of lines (5 letters per line) read correctly.
Measured: Day 90
Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90
Change from Baseline in corneal topography of the worse eye as measured using a Pentacam system which calculates a number. Corneal topography is a non-invasive medical imaging technique for mapping the surface of the eye. The Pentacam system measures the pupil and anterior segment (the front part of the eye) which provides a range from 10 (best) to 60 (worst). A negative number change from baseline indicates an improvement.
Measured: Baseline, Day 90
Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90
Change from Baseline in corneal topography of the worse eye as measured by a Humphrey Atlas system which calculates a number. Corneal topography is anon-invasive medical imaging technique for mapping the surface curvature of the cornea (the outer structure of the eye). The higher the number the more irregular the cornea. A Humphrey Atlas system detects irregular conditions in the cornea with a range from 0 = best to 2.5 = worst. A negative number change from baseline indicates an improvement.
Measured: Baseline, Day 90
Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90
Change from Baseline in total HOA of the worse eye. The total HOA number is measured using a machine that calculates and detects changes in the cornea which could occur post Lasik surgery. A negative number change from baseline indicates an improvement.
Measured: Baseline, Day 90
Change From Baseline of the Worse Eye in Schirmer's Test at Day 90
Change from baseline in Schirmer's Test results at Day 90 in the worse eye. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears). The smaller the number, the more severe the dry eye.
Measured: Baseline, Day 90
Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90
Change from Baseline in corneal staining of the worse eye at Day 90. Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement).
Measured: Baseline, Day 90
Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90
Change from Baseline in conjunctival staining of the worse eye using Lissamine Green staining procedure. Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), with a minimum score of 0 and a maximum score of 30. The higher the grade score, the worse dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).
Measured: Baseline, Day 90
Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90
Change from Baseline in TBUT of the worse eye at Day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).
Measured: Baseline, Day 90
Change From Baseline in Study Product Usage at Day 90
Change from baseline in the study product usage (average number of uses per day) at Day 90. A negative number change from baseline indicates a reduction in eye drop usage (improvement).
Measured: Baseline, Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Jun 2008

First posted16 Oct 2007 (estimated)
Study startSep 2007
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00544713
Sponsor's protocol ID: AG9818-001
Status last verified: Nov 2011
First submitted: 12 Oct 2007
Last updated: 14 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery
ClinicalTrials.gov ID: NCT00544713
Acronym / sponsor ID: AG9818-001
Conditions: Dry Eye Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 16 Oct 2007 (estimated)
Results: Posted 14 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Carboxymethylcellulose and Glycerin based artificial tear	Experimental	Drug: Carboxymethylcellulose and Glycerin based artificial tearCarboxymethylcellulose and Glycerin based artificial tear
Carboxymethylcellulose based artificial tear	Active comparator	Drug: CarboxymethylcelluloseCarboxymethylcellulose based artificial tear

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters

Key exclusion criteria (5 listed)

Dry eye signs and symptoms
Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively
Pregnancy or planning pregnancy
Uncontrolled systemic disease
Use of systemic medications affecting dry eye

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Carboxymethylcellulose and Glycerin based artificial tearAs directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake	Drug	Carboxymethylcellulose and Glycerin based artificial tear
CarboxymethylcelluloseAlso: Refresh Plus®As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake	Drug	Carboxymethylcellulose based artificial tear

Primary outcome

Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90
Time frame: Day 90
Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).

11 secondary outcomes

Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
Time frame: Day 90
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
Time frame: Day 90
Best Corrected Visual Acuity (BCVA) Status at Day 90
Time frame: Day 90
Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90
Time frame: Baseline, Day 90
Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90
Time frame: Baseline, Day 90
Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90
Time frame: Baseline, Day 90
Change From Baseline of the Worse Eye in Schirmer's Test at Day 90
Time frame: Baseline, Day 90
Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90
Time frame: Baseline, Day 90
Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90
Time frame: Baseline, Day 90
Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90
Time frame: Baseline, Day 90
Change From Baseline in Study Product Usage at Day 90
Time frame: Baseline, Day 90

Results and safety

Results posted to the registry on 14 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carboxymethylcellulose and Glycerin Based Artificial Tear	114	111
Carboxymethylcellulose Based Artificial Tear	114	109

Primary outcome: Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90

Time frame: Day 90. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Carboxymethylcellulose and Glycerin Based Artificial Tear n = 114	Carboxymethylcellulose Based Artificial Tear n = 114
Value	8.32 (11.125)	6.43 (8.036)

Population analysed: Intent to Treat population defined as all patients who started the study and were randomized

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carboxymethylcellulose and Glycerin Based Artificial Tear	0 of 114 (0%)	88 of 114 (77.2%)	Not reported
Carboxymethylcellulose Based Artificial Tear	0 of 114 (0%)	82 of 114 (71.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Carboxymethylcellulose and Glycerin based artificial tear and Carboxymethylcellulose in people with Dry Eye Syndrome, run by Allergan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00544713.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2011.